- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04899557
Retrospective/Prospective Study of Pediatric Surgical Patients
March 2, 2022 updated by: Greg Klazura, University of Illinois at Chicago
UIC Division of pediatric surgery has IRB approval to perform retrospective and prospective study of their pediatric surgical patients.
At UIC Dr. Lobe performed the first known single port robotic splenectomy on a child and as a surgical first this case is worthy of a case report.
Since it is a surgical and therapeutic first it needs to be aon regestiry of health research prior to publication.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- Office for the Protection of Research Subjects
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 second to 18 years (Child, Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
pediatric patient with splenomegaly
Description
Inclusion Criteria:
- Pediatric patient with splenomegaly
Exclusion Criteria:
- NOn pediatric patients
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality
Time Frame: 30 days post op
|
Did the patient die from the operation
|
30 days post op
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Greg Klazura, University of Illinois at Chicago
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 27, 2021
Primary Completion (Actual)
May 1, 2021
Study Completion (Actual)
May 1, 2021
Study Registration Dates
First Submitted
May 19, 2021
First Submitted That Met QC Criteria
May 19, 2021
First Posted (Actual)
May 24, 2021
Study Record Updates
Last Update Posted (Actual)
March 3, 2022
Last Update Submitted That Met QC Criteria
March 2, 2022
Last Verified
May 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 2014-0396
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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